POS1023 LONG-TERM SAFETY OF RISANKIZUMAB IN PATIENTS WITH PSORIATIC DISEASE: FINDINGS FROM INTEGRATED ANALYSES OF 17 CLINICAL TRIALS IN PSORIASIS AND 4 IN PSORIATIC ARTHRITIS
Authors: K. B. Gordon, A. Blauvelt, H. Bachelez, B. Kaplan, W. Koetse, L. Drogaris, R. Sinvhal, K. Papp
Journal: Annals of the Rheumatic Diseases (2022)

Background Risankizumab, an interleukin-23 inhibitor, was efficacious and well tolerated in phase 2 and 3 clinical studies in patients with psoriatic disease. Objectives To report long-term risankizumab safety in patients with psoriatic disease. Methods Risankizumab safety data to March 25, 2021 were pooled from 17 phase 1–3 clinical trials in plaque psoriasis (PsO) and 4 phase 2/3 trials in psoriatic arthritis (PsA). Adverse events (AEs) of safety interest were reported for patients receiving ≥1 dose risankizumab. Results Among 3197 patients with PsO (9982.6 patient years’ [PY] exposure; median (range) treatment duration, 3.7 years [1 day–6.9 years]) and 1542 patients with PsA (1594.9 PY; 1.0 year [84 days–2.0 years]), rates of treatment-emergent AEs (158.3 and 160.8 events (E)/100PY), serious AEs (7.6 and 8.4 E/100PY) and AEs leading to discontinuation (1.9 and 2.3 E/100PY) were similar. Nasopharyngitis (PsO 14.5 E/100PY, PsA 7.9 E/100PY) and upper respiratory infection (PsO 7.8 E/100PY, PsA 5.6 E/100PY) were the most common infections; sepsis and pneumonia for PsO (0.1 E/100PY each) and COVID-19 for PsA (0.4 E/100PY) were the most common serious infections. Rates of opportunistic fungal infections were &lt;0.1 and 0.1 E/100PY in PsO/PsA patients. Rates of non-melanoma skin cancer (NMSC) were 0.7 and 0.4 E/100PY, and malignant tumors excluding NMSC were 0.6 and 0.3 E/100PY in PsO/PsA patients. Rates of major adverse cardiovascular events were 0.5 and 0.4 E/100PY in PsO/PsA patients. Conclusion Rates of AEs of safety interest remained low in this largest and longest safety reporting for risankizumab to date, supporting the safety of risankizumab for the long-term treatment of patients with psoriatic disease. References [1]Gordon KB, et al. Lancet . 2018;392(10148):650-61. [2]Reich K, et al. Lancet . 2019;394(10198):576-86. [3]Blauvelt A, et al. JAMA Dermatol . 2020;156(6):649-58. Acknowledgements AbbVie funded the study, contributed to its design and participated in data collection, analysis and interpretation of the data, and in writing, review, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Moira Hudson, PhD, and Janet Matsuura, PhD, of ICON (North Wales, PA, USA) and was funded by AbbVie Inc. Disclosure of Interests Kenneth B. Gordon Consultant of: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly, GlaxoSmithKline, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi-Aventis, Sun, and UCB, Grant/research support from: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly, GlaxoSmithKline, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi-Aventis, Sun, and UCB, Andrew Blauvelt Consultant of: AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly and Company, Evommune, Forte, Galderma, Incyte, Janssen, Landos, Leo, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma, Grant/research support from: AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly and Company, Evommune, Forte, Galderma, Incyte, Janssen, Landos, Leo, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma, Hervé Bachelez Speakers bureau: AbbVie, Almirall, Amgen, Bayer, Baxalta, Biocad, Boehringer Ingelheim, Celgene, Dermavant, Eli Lilly, Janssen, Leo Pharma, Menarini, MSD, Novartis, Pfizer, Pierre Fabre, Sandoz, Sun Pharmaceuticals, and UCB, Consultant of: AbbVie, Almirall, Amgen, Bayer, Baxalta, Biocad, Boehringer Ingelheim, Celgene, Dermavant, Eli Lilly, Janssen, Leo Pharma, Menarini, MSD, Novartis, Pfizer, Pierre Fabre, Sandoz, Sun Pharmaceuticals, and UCB, Grant/research support from: AbbVie, Almirall, Amgen, Bayer, Baxalta, Biocad, Boehringer Ingelheim, Celgene, Dermavant, Eli Lilly, Janssen, Leo Pharma, Menarini, MSD, Novartis, Pfizer, Pierre Fabre, Sandoz, Sun Pharmaceuticals, and UCB, Blair Kaplan Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Willem Koetse Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Leonidas Drogaris Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Ranjeeta Sinvhal Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Kim Papp Speakers bureau: AbbVie, Amgen, Arcutis, Astellas, Avillion, Bausch Health, Baxalta, Baxter, Boehringer Ingelheim, Botanix, Bristol-Myers Squibb, Celgene, Coherus, Dermavant, Dermira, Eli Lilly, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, Leo Pharma, Meiji Sika Pharma, MedImmune, Merck-Serono, Merck Sharp &amp; Dohme, Mitsubishi, Novartis, Pfizer, Regeneron, Roche, Samsung Biopepis, Sanofi-Genzyme, Stiefel, Sun Pharma, Takeda, UCB, and Valeant, Consultant of: AbbVie, Amgen, Arcutis, Astellas, Avillion, Bausch Health, Baxalta, Baxter, Boehringer Ingelheim, Botanix, Bristol-Myers Squibb, Celgene, Coherus, Dermavant, Dermira, Eli Lilly, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, Leo Pharma, Meiji Sika Pharma, MedImmune, Merck-Serono, Merck Sharp &amp; Dohme, Mitsubishi, Novartis, Pfizer, Regeneron, Roche, Samsung Biopepis, Sanofi-Genzyme, Stiefel, Sun Pharma, Takeda, UCB, and Valeant, Grant/research support from: AbbVie, Amgen, Arcutis, Astellas, Avillion, Bausch Health, Baxalta, Baxter, Boehringer Ingelheim, Botanix, Bristol-Myers Squibb, Celgene, Coherus, Dermavant, Dermira, Eli Lilly, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, Leo Pharma, Meiji Sika Pharma, MedImmune, Merck-Serono, Merck Sharp &amp; Dohme, Mitsubishi, Novartis, Pfizer, Regeneron, Roche, Samsung Biopepis, Sanofi-Genzyme, Stiefel, Sun Pharma, Takeda, UCB, and Valeant